DISEASE SPECIFIC PATIENT REPORTED OUTCOME MEASURES IN ATRIAL FIBRILLATION: SYSTEMATIC REVIEW AND ASSESSMENT OF THE MEASUREMENT PROPERTIES

   Purpose: The aim of this study was to compare, critically appraise, and synthesize evidence on the quality of measurement properties of the available disease specific patient reported outcome measures (PROMs) for health related quality of life (HRQOL) in patients with atrial Fibrillation (AF).

   Methods: We performed a systematic search in PubMed and EMBASE (February 13, 2015). We utilized a two-step approach to perform the literature search. First, we identified the PROMs used in AF studies.  We then used the bibliographic references and name searches of the identified PROMs to identify the studies that evaluated the psychometric properties of the PROMs. We excluded studies in which PROMs was not self-administered and studies that did not use PROMs. We performed the psychometric evaluation according to the COnsensus-based Standards for the selection of the health Measurements INstruments (COSMIN) checklist. The study quality of the development and validation studies was evaluated on the four-point scale ranging from excellent to poor, per disease specific instrument in AF.

   Results: Our search strategy returned 1,209 studies, of which 157 used a PROM, either generic or disease specific. We identified 34 instruments used in AF, five of which were disease specific. One of the AF specific PROMs was published in Spanish, one in Japanese, and four in English. We performed the summarized and evaluation of measurement properties of five disease specific PROMs based on the COSMIN checklist method. According to COSMIN checklist, only one of the five AF specific PROMs – the Atrial Fibrillation Effect on QualiTy of Life (AFEQT) - was rated as good to excellent for use in the AF population. For the other four AF specific PROMs, the evidence of measurement error, construct validity, and hypothesis testing were missing from the validation studies; and the responsiveness evidence was incongruous with COSMIN taxanomy.

 Conclusion: Based on the results of our systematic review and assessment of measurement properties, there are few well-developed and validated disease specific PROMs for use in AF. Only one AF specific PROM met the comprehensive requirements set forth by the COSMIN checklist.